A Prospective, Randomized, Staggered-onset, Double Blinded, Sham-Controlled Study to Evaluate Peripheral Vibrotactile Coordinated Reset (CR) Stimulation for Parkinson’s Disease
Sponsor:
Brief Summary:
Parkinson’s disease seeks to explore the safety and efficacy of an experimental non-invasive
method to aid in the symptoms of Parkinson’s disease. The purpose of the study is to verify
the safety and tolerability of non-painful sensory (tactile) vibratory stimulation delivered
to the fingertips of patients with Parkinson’s disease.
Criteria
1. Age 18 and older
2. Diagnosis of idiopathic Parkinson’s disease.
3. Levodopa responsiveness as defined by at least a 30% reduction in MDS-UPDRS motor
subscale (excluding tremor scores) in the ON vs OFF medication state.
4. Willing to participate in the vibrotactile stimulation sessions for 2 consecutive days
initially and willing to return for follow-up visits
5. Able to provide informed consent.
6. Appropriate social support
Exclusion Criteria:
1. Hoehn and Yahr stage greater than 3 in the on medication state
2. Presence of other forms of non-idiopathic parkinsonism, including but not limited to
atypical parkinsonism, medication induced parkinsonism, vascular Parkinsonism
3. Any illness that in the investigator’s opinion precludes participation in the study
4. Subjects unable to communicate with the investigator and staff
Locations
- Stanford University, Stanford, California, United States, 94305
